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TRAINING ON THE US GOVERNMENT
POLICY FOR INSTITUTIONAL
OVERSIGHT OF LIFE SCIENCES DUAL
USE RESEARCH OF CONCERN
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Purpose
This presentation provides an overview of the
US Government Policy for Institutional
Oversight of Life Sciences Dual Use Research
of Concern (DURC)
The slides may be used to:
promote understanding of the issues associated
with dual use research in the life sciences
highlight the importance of the need for responsible
conduct and oversight of such research, and
educate on the specific requirements of individuals
and entities under the Policy
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Overview of Training
What is Dual Use Research in the Life
Sciences?
Oversight of Dual Use Research of Concern
Key Responsibilities of Institutions,
Investigators, the U.S. Government, and
Others under the Institutional DURC
Oversight Policy
Resources, including the “Companion Guide”
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DUAL USE RESEARCH
IN THE LIFE SCIENCES
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Importance of Life Sciences Research
Life sciences research underpins:
Biomedical and public health advances
Improvements in agriculture
Safety and quality of food supply
Environmental quality
Strong national security and economy
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Dual Use Research In The Life Sciences
Good science can be put to bad uses
Dual use research (DUR) is research
conducted for legitimate purposes that
generates knowledge, information,
technologies, and/or products that can be
utilized both for benevolent and harmful
purposes
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Dual Use Research of Concern (DURC)
Most life sciences research conceivably could be
considered DUR in that it has some potential to
generate information that could be misused
There is a subset of research that has the greatest
potential for generating information that could be
readily misused in ways that threaten public health
and national security. Such research has been
termed
(DURC) and is
the focus of the US Government oversight policies
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US Government Definition of DURC
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OVERSIGHT OF DUAL USE
RESEARCH OF CONCERN
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Oversight of DURC
The dual use potential of certain life sciences
research has been recognized as an important
biosecurity issue for a number of years
Managing the risks associated with DURC is a
responsibility shared by:
Researchers
Journal editors and publishers
Institutional officials
Local oversight bodies
The Federal government
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US Government Policies for
DURC Oversight
There are two US Government policies that
address the oversight of life sciences DURC.
The United States Government Policy for Oversight
of Life Sciences Dual Use Research of Concern
(March 2012)
The United States Government Policy for
Institutional Oversight of Life Sciences Dual Use
Research Of Concern (September 2014)
Available at www.phe.gov/s3/dualuse
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US Government Policies for DURC Oversight
These policies:
Aim to preserve the benefits of life sciences research
while minimizing the risk of misuse of the knowledge,
information, products, or technologies provided by such
research; and
Complement existing regulations and policies governing
the safe and secure use of pathogens and toxins
Whereas the March 2012 policy describes the
responsibilities of Federal agencies, the
September 2014 policy primarily describes the
responsibilities of institutions
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Research Subject to the Policies
Does research
involve one or
more of 15 agents
or toxins listed in
the Policy?
Does research aim
to produce one of
seven listed
experimental
effects?
Does research
meet definition
of DURC?
nal Federal
ght and risk
tegies to
e concerns
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The US Government Policy for Oversight of
Life Sciences DURC (March 2012)
Requires Federal departments and agencies
to review their research portfolios, both
intramural and extramural, to:
Identify all research under the policy with DURC
potential
Mitigate the risks posed by any DURC identified
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The USG Policy for Institutional
DURC Oversight (September 2014)
Institutional oversight of DURC is a
critical component of a comprehensive
oversight system that involves:
Principal Investigators (PIs)
Institutional Review Entity (IRE)
Institutional Contact for Dual Use Research
(ICDUR)
Institution
United States Government (USG)
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Overview of the Process for
Institutional DURC Oversight
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Entities Subject to the
Institutional DURC Oversight Policy
Federal departments and agencies that fund or
conduct life sciences research
Institutions within the United States that:
Receive Federal funds to conduct or sponsor life
sciences research; and
Conduct or sponsor research that is subject to the Policy,
regardless of source of funding
Institutions outside of the United States that
receive Federal funds to conduct or sponsor
research subject to the Policy
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What Research is Subject to the Policy?
Research that uses one or more of the
agents or toxins listed in the Policy to
discern if it:
Produces, aims to produce, or can be
reasonably anticipated to produce one or
more of the seven listed experimental
effects
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What Research is Subject to the Policy?
Research that directly involves any of the
following 15 agents and toxins*
Avian influenza virus (highly pathogenic)
Bacillus anthracis
Botulinum neurotoxin (in any quantity)
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
Francisella tularensis
Marburg virus
Reconstructed 1918 Influenza virus
Rinderpest virus
Toxin-producing strains of Clostridium botulinum
Variola major virus
Variola minor virus
Yersinia pestis
*
Except attenuated strains of the agents that are excluded from the
Select Agent list and inactive forms of botulinum neurotoxin
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What Research is Subject to the Policy?
Experimental effects
Enhances the harmful consequences of the agent or toxin
Disrupts immunity or the effectiveness of an immunization
against the agent or toxin without clinical and/or agricultural
justification
Confers to the agent or toxin resistance to clinically and/or
agriculturally useful prophylactic or therapeutic interventions
against that agent or toxin or facilitates their ability to evade
detection methodologies
Increases the stability, transmissibility, or the ability to
disseminate the agent or toxin
Alters the host range or tropism of the agent or toxin
Enhances the susceptibility of a host population to the agent
or toxin
Generates or reconstitutes an eradicated or extinct agent or
toxin listed in the policy
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Determine if the Research
Meets the Definition of DURC
If the research with any of the 15 agents involves any of
the 7 experimental effects, conduct a risk assessment to
determine if it meets the following definition:
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Risk Assessment and Risk Mitigation
For projects that are determined to
meet the definition of DURC, the IRE
must develop a risk mitigation plan to
apply any necessary and appropriate
risk mitigation measures
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Management of DURC-Associated Risks
DURC risk mitigation strategies may include:
Changing the design or conduct of the research or not
conducting certain aspects of DURC
Applying specific biosecurity and/or biosafety measures
Developing a plan for monitoring the research for findings
with additional DURC potential
Developing plan for responsibly communicating the results
of DURC
In
instances, when appropriate, restricting
communication of experimental details or other specific
information
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KEY RESPONSIBILITIES
OF INSTITUTIONS
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Key Responsibilities of Institutions
Establish and implement policies and practices
for identification and oversight of DURC that
include:
Establishing an IRE
Ensuring appropriate review of research with
DURC potential
Assessing the potential risks and benefits
associated with DURC
Developing and implementing risk mitigation plans,
as necessary
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Key Responsibilities of Institutions
… continued
Ensuring compliance with the Policy and
approved risk mitigation plans
Ensuring periodic review and updating of risk
mitigation plans
Providing education and training on DURC
Assisting investigators when questions arise
regarding research that may be subject to the
Policy
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Key Responsibilities of Institutions
Notify USG funding agencies of:
Research reviewed by the IRE that involves one of
the seven experimental effects, including whether
the research is determined to be DURC
Instances of noncompliance with the Policy
Proposed risk mitigation plans for research
determined to be DURC
Changes in status of DURC or modification to risk
mitigation plans
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KEY RESPONSIBILITIES OF
INVESTIGATORS
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Key Responsibilities of Investigators
Identify and refer to the IRE all research
involving one or more of the agents or
toxins listed in the Policy, along with an
assessment of whether the research
involves any of the seven listed
experimental effects
Work with the IRE to assess the dual use
risks and benefits of the research in
question and develop risk mitigation
measures
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Key Responsibilities of Investigators
Conduct DURC in accordance with the risk
mitigation plan
Be knowledgeable about and comply with all
institutional and Federal policies and
requirements for oversight of DURC
Continue to assess research to determine if,
at any time, the research becomes subject to
the policy
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Key Responsibilities of Investigators
Ensure that laboratory personnel (e.g.
graduate students, postdoctoral fellows,
research technicians, laboratory staff, and
visiting scientists) conducting research with
any of the 15 listed agents have received
education and training on DURC
Communicate DURC in a responsible manner,
throughout the research process, not only at
the point of publication
Ensure that communication is in compliance
with the risk mitigation plan approved by the
appropriate Federal funding agency
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KEY RESPONSIBILITIES OF THE
INSTITUTIONAL REVIEW ENTITY (IRE)
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Key Responsibilities of the IRE
Be composed of at least 5 members, including
persons with knowledge of US government policies
and sufficient range of expertise to assess the dual
use potential of research conducted at that institution
Review of research identified by PIs:
1.
2.
3.
Verification that the research involves one or more of the 15
listed agents
Review of the PIs assessment and final determination of
whether the research meets any of the seven experimental
effects
When appropriate, make a determination of whether the
research meets the definition of DURC
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Key Responsibilities of the IRE
For research determined to be DURC,
the IRE:
Consider the risks and benefits of conducting the
research
Works with the appropriate Federal funding agency
to develop a risk mitigation plan
Reviews the risk mitigation plan at least annually
and modifies the plan, as warranted
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KEY RESPONSIBILITIES OF THE
INSTITUTIONAL CONTACT FOR
DUAL USE RESEARCH (ICDUR)
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Key Responsibilities of the ICDUR
Serve as institutional point of contact for questions
regarding compliance with and implementation of the
requirements for the DURC oversight policies
Serve as liaison between the institution and the
relevant USG funding agency
Consult with the relevant USG funding agency when
the institution seeks advice on matters related to
DURC
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KEY RESPONSIBILITIES OF US
GOVERNMENT FUNDING AGENCIES
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Key Responsibilities of
US Government Funding Agencies
Require policy implementation at all institutions
subject to the Policy.
When notified by an institution of research meeting the
scope of the Policy:
Notify the institution when the USG funding agency
disagrees with any part of the IRE’s review outcome
For research determined to be DURC, work with the
institution to finalize a risk mitigation plan
Respond to questions from institutions regarding
DURC oversight and compliance with the Policy
Respond to reports of non-compliance and work with
the institution to address such non-compliance
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KEY RESPONSIBILITIES OF
THE US GOVERNMENT
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Key Responsibilities of the
US Government
Provide guidance to institutions regarding review,
management, and responsible communication of
DURC
Develop training tools and materials for use by the
USG agencies and institutions implementing the
Policy
Provide education and outreach to stakeholders
about dual use policies and issues
Assess periodically the impact of the Policy on life
sciences research programs and, as appropriate,
update the Federal and institutional dual use research
oversight policies
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RESOURCES
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Resources
Companion Guide
A compendium of tools to assist investigators and research
institutions in the implementation of DURC oversight
Case Studies
Provide a range of examples of research that is subject to the
policy and demonstrate the type of analysis that should be
brought to bear during institutional reviews
These tools promote the:
understanding and identification of DURC
risk assessment and development of risk mitigation
plans and risk management processes
responsible communication of DURC, and training and
education on DURC
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Companion Guide
Available at: www.phe.gov/s3/dualuse
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Companion Guide
The Companion Guide includes:
Frequently asked questions regarding US Government DURC
oversight policies
Guidance for PIs on identification and assessment of research
that requires institutional review
Guidance for IREs on conducting institutional review,
including risk assessments and drafting and review of risk
mitigation plans
Guidance to all audiences on responsible communication of
DURC
Templates (optional) for institutions to use in fulfilling policy
requirements
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Case Studies
Insert image of front
page of case studies
Available at www.phe.gov/s3/dualuse
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Available on YouTube:
http://www.youtube.com/watch?v=0yS1ur24j40
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Investigator Brochures
To request copies email: PBBP@od.nih.gov
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Poster
To request copies email: PBBP@od.nih.gov
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Additional Information
Information about dual use research in the
life sciences as well as specific details on the
United States Government Policy for
Institutional Oversight of Life Sciences Dual
Use Research of Concern can be found at:
www.phe.gov/s3/dualuse
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Implementation Questions
Questions about implementing the Policy
may be sent to:
DURC@ostp.gov